Phase 2 N=147 Randomized Quadruple-blind Treatment

Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients

Post-surgical Pain

Bottom Line

View on ClinicalTrials.gov: NCT03599089 ↗

Enrolled (actual)

147

Serious AEs

0.7%

Results posted

Aug 2021

Primary outcome: Primary: Change in Postsurgical Pain Based on the Weighted Sum of Pain Intensity (SPI) Assessments Over 96 Hours of the NRS Scores = Area Under the Curve (AUC) — 317.09; 321.72; 266.86; 400.56 scores on a scale*hour — p=0.005

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: CA-008 (Drug); Placebo (Drug); Ketorolac (Drug); Acetaminophen (Drug); Oxycodone (Drug); Bupivacaine Hydrochloride (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Concentric Analgesics
Primary completion: Oct 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Postsurgical Pain Based on the Weighted Sum of Pain Intensity (SPI) Assessments Over 96 Hours of the NRS Scores = Area Under the Curve (AUC)	317.09; 321.72; 266.86; 400.56	0.005 sig
SECONDARY Percentage of Subjects Opioid Free	19.4; 16.7; 26.3; 5.4	0.0245 sig
SECONDARY Total Opioid Consumption (in Daily Morphine Equivalents)	42.50; 37.71; 28.22; 56.11	0.0019 sig

Summary

This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel design study evaluating a single dose of one of three CA-008 dose levels vs. placebo injected during an elective bunionectomy Bunionectomy to assess post-surgical pain management and the need for rescue medication (oxycodone).

Eligibility Criteria

Inclusion Criteria

Healthy adult aged 18 - 75 years old
American Society of Anesthesiology (ASA) physical Class 1, 2 or 3
Planning elective Bunionectomy repair
For both males and females: using an acceptable method of birth control
If a female: not pregnant or breastfeeding
Have a body mass index ≤ 40 kg/m2.
Be willing and able to sign the informed consent form (ICF)
Be able to complete study procedures and pain scales and to communicate meaningfully in English
Be willing to undergo 17 blood draws for pharmacokinetic (PK )assessments over 24 hours

Exclusion Criteria

Have another painful condition, other than bunion-related pain, that may require pain treatment during the study period
Have active skin disease or another abnormality at the anticipated site of surgery that could interfere with the planned surgery.
Have a known allergy to chili peppers, capsaicin or the components of CA-008, bupivacaine HCl, ketorolac, acetaminophen or oxycodone.
Have a history of significant medical, neuropsychiatric or other condition, including a clinically significant abnormal clinical laboratory test values
Be on any medication not allowed per the protocol
Within the past year have a history of illicit drug use or prescription medicine or alcohol abuse
Have positive results on the alcohol test (breath or saliva) or urine drug screen
Have previously participated in a clinical study with CA-008.
Have participated in another clinical trial or used an investigational product within 30 days or five half-lives (whichever is longer)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03599089). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.